Effects of single-pill combination of telmisartan/amlodipine and telmisartan/amlodipine/hydrochlorothiazide on 24-hour blood pressure (BP) reduction, 24-h BP variability and office BP control in patients with arterial hypertension – SATELLITE
Key facts
- Where
- Biatorbágy, Makó és Tiszacsege, MagyarországSee the 3 sites
- Phase
- 4. fázis
Where in Magyarország
- Biatros Kft.Biatorbágy, MagyarországNo longer taking part
- Egészségedre Kft.Makó, MagyarországNo longer taking part
- Vitalmed 2003 Bt.Tiszacsege, MagyarországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- KRKA tovarna zdravil d.d. Novo mesto
- Trial code
- EU 2023-504812-13-00
- Record updated
- 2025. augusztus 22.
- Original description
To assess efficacy of treatment with single-pill combination (SPC) of telmisartan/amlodipine (T/A) and SPC of telmisartan/amlodipine/hydrochlorothiazide (T/A/HCTZ) on 24-hour blood pressure (BP) reduction after 16 weeks of treatment in patients with Grade 1, Grade 2 or Grade 3 arterial hypertension.Read full original descriptionShow less
To assess efficacy of treatment with single-pill combination (SPC) of telmisartan/amlodipine (T/A) and SPC of telmisartan/amlodipine/hydrochlorothiazide (T/A/HCTZ) on 24-hour blood pressure (BP) reduction after 16 weeks of treatment in patients with Grade 1, Grade 2 or Grade 3 arterial hypertension.
Inclusion: Patients with diagnosed Grade 1, Grade 2 or Grade 3 Arterial Hypertension at Visit 1 AND Visit 2; Average 24-hour SBP ≥130 mmHg AND/OR average 24-hour DBP ≥80 mmHg, obtained by the ambulatory blood pressure monitoring (ABPM) device at the study baseline; Patients who are treatment-naïve OR uncontrolled on: existing antihypertensive monotherapy or dual combinational therapy (except those on telmisartan and amlodipine therapy); Female or male patients, aged ≥18 years; Patients with ability to adhere to the trial protocol according to the investigator’s judgement; Patients who have been provided with information about the trial and have voluntarily signed the informed consent; Patients who have signed the consent for collection, analysis and processing of personal data, that will be collected during this clinical trial for the purpose of statistical analysis and final report of this clinical trial.
Exclusion: Previous or current antihypertensive therapy with telmisartan and amlodipine taken concomitantly or as single-pill combination; Any of the following laboratory or ECG findings: significant anaemia with haemoglobin less than 100 g/L, abnormal values of serum potassium (i.e. hypo- and hyperkalaemia; with reference to the normal laboratory values) that are clinically significant according to the investigator’s judgement, hypercalcaemia (with reference to the normal laboratory values) that is clinically significant according to the investigator’s judgement, atrioventricular (A-V) block grade 2 or 3, ECG signs of acute ischemia; Renal impairment – GFR <45 ml/min/1.73 m2 (e.g. bilateral renal artery stenosis, renal artery stenosis in a solitary kidney or post-renal transplant patients, dialysis patients, anuria); Concomitant therapy with: pressor amines, lithium, digoxin, aliskiren-containing products, drugs that can provoke hyperkalaemia: potassium supplements, or potassium-containing salt substitutes, drugs that may reduce the antihypertensive effect: systemic corticosteroids; Non-compliance with 24-hour BP measurement quality criteria.